DSL ESTRONE-SULFATE RIA— 510(k) K970915

Name: FDA 510(k) clearance K970915
Creator: U.S. Food and Drug Administration
Published: 1997-05-16

Substantially Equivalent

Diagnostic Systems Laboratories, Inc.

FDA 510(k) clearance K970915 for DSL ESTRONE-SULFATE RIA, Substantially Equivalent on 1997-05-16. Applicant: Diagnostic Systems Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Diagnostic Systems Laboratories, Inc.
Product code: Code CGF
Device class: Class 1
Regulation: 21 CFR 862.1280
Advisory panel: Clinical Chemistry
Date received: 1997-03-12
Decision date: 1997-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Webster, TX, US

Download summary PDF View on FDA.gov ↗

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